Kornimate/medical-research-clean huggingface dataset:
safety and efficacy evaluation of s (+) - ketamine in adults

Conditions: Postoperative Pain; Adults; Anesthesia

Summary: a multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of s (+) -ketamine for postoperative acute pain in adults in perioperative settings.

patients often suffer acute pain after operation ，which may affect the recovery. opioid such as morphine is the most commonly analgesic drugs, but opioid has many obviously adverse reactions ,for example respiratory depression,circulation inhibition,tolerance, addiction, nausea, vomiting, pruritus, etc. s (+) - ketamine has been described to decrease acute pain and opioid consumption,but it needs to confirm for chinese patients undergoing surgery. objective:evaluate the efficacy and safety of s (+) - ketamine on acute perioperative pain for chinese adult patients,and look for the best dosage, mode of administration, timing, and compatibility ,as well explore the effect of s (+) - ketamine on postoperative delirium,anxiety ,depression and cognitive dysfunction.

Eligibility criteria:
inclusion criteria: * 1. age ≥18 years old; * 2. scheduled for elective digestive tract surgery, gynecological surgery, urological surgery, thoracic surgery, orthopedic limb surgery, orthopedic spine surgery or body surface surgery (thyroid surgery or breast surgery), head and neck surgery; * 3. asa score ⅰ～ⅲ; * 4. the informed consent form was signed by the patients. exclusion criteria: * 1. the expected length of hospital stay of the patient is less than 48h; * 2. patients expected to be admitted to the icu after surgery; * 3. patients expected to return to the ward with tracheal catheter after surgery; * 4. be allergic to s (+) - ketamine; * 5. patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction; * 6. patients with a history of severe cardiovascular disease (congestive heart failure, severe angina attack, or unstable angina or myocardial infarction within 6 months); * 7. patients during pregnancy or lactation; * 8. patients with mmse score \<18 points; * 9. patients with any of the following contraindications of s (+) - ketamine: 1. patients with risk of serious rise of blood pressure or intracranial pressure; 2. patients with high intraocular pressure (glaucoma) or penetrating ocular trauma; 3. patients with poorly controlled or untreated hypertension (resting systolic blood pressure greater than 180 mmhg, or resting diastolic blood pressure greater than 100mmhg); 4. patients with untreated or undertreated hyperthyroidism.

Keywords: s-ketamine,esketamine,s (+) - ketamine acute pain depression, anxiety delirium hyperalgesia
the efficacy of n-acetyl-cysteine in the treatment of burning mouth syndrome

Conditions: Burning Mouth Syndrome

Summary: the purpose of this study was to examine the efficacy of n-acetyl cysteine in the treatment of burning mouth syndrome. a control group of patients with burning mouth syndrome will receive a placebo. the effect of the therapy will be monitored with the help of the visual-analogue scale (vas) and the oral health-related quality of life questionnaire (ohip-14).

the research will include patients who come to the department of oral medicine at the faculty of dentistry in zagreb, and who have been diagnosed with burning mouth syndrome. it is planned to gather a total of 60 patients, 30 patients in the treatment group and 30 in the placebo group. the purpose and protocol of the research will be explained to the patients. if they are willing to participate, they will sign an informed consent previously approved by the ethics committee of the faculty of dentistry. they will fill in the ohip-14 questionnaire and the vas scale, grading from 0-10, where 0 indicates a condition without symptoms, and 10 the strongest possible intensity of symptoms. they will be randomly assigned to a therapeutic or placebo group and will receive the medicine in an unmarked box. the drug will be taken for two months at a dose of 1200 mg per day. after that, they will come for a check-up and re-complete ohip-14 and record the intensity of symptoms according to the vas scale.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of burning mouth syndrome exclusion criteria: * pregnancy, breastfeeding or pregnancy planning * anamnestic data about active gastric or duodenal ulcer * decreased levels of serum iron or b vitamins
influenza vaccine in pregnancy part 2

Conditions: Influenza; Pregnancy

Summary: pregnant women have limited knowledge regarding influenza, its implications during pregnancy, and recommendations for vaccination during pregnancy. the researchers plan to distribute an information pamphlet to women in a prenatal clinic, offer the vaccine during prenatal visits, and then give a questionnaire on the postpartum floor assessing knowledge. the researchers hypothesize that with education intervention, knowledge scores on the questionnaire will be higher than those from last year, when no education was provided.


Eligibility criteria:
inclusion criteria: * all pregnant women exclusion criteria: * known hypersensitivity to influenza vaccine

Keywords: influenza vaccine pregnancy
steroids added to dithranol and narrow band uvb(ultraviolet b) (uvbnb) in psoriasis

Conditions: Psoriasis

Summary: objective(s): (i) to assess the effect of adjunctive topical steroids in the combined treatment with uvbnb and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50% loss of pasi (psoriasis area and severity index) improvement obtained through the antecedent treatment. (ii) to assess the impact of adjuvant topical steroids in the combined treatment with uvbnb and dithranol on the clearing time of psoriasis lesions under therapy (pasi 75). * trial with medicinal product

(i) to assess the effect of adjunctive topical steroids in the combined treatment with uvbnb and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50% loss of pasi (psoriasis area and severity index) improvement obtained through the antecedent treatment. (ii) to assess the impact of adjuvant topical steroids in the combined treatment with uvbnb and dithranol on the clearing time of psoriasis lesions under therapy (pasi 75). * trial with medicinal product

Eligibility criteria:
inclusion criteria: * moderate to severe psoriasis of the chronic-plaque and / or guttata type exclusion criteria: * participation in a goeckerman therapy regimen within 6 months previous to the present study
family-focused cbt skills app and standard self help options for childhood anxiety

Conditions: Anxiety Disorders; Childhood Mental Disorder; Anxiety

Summary: anxiety disorders are among the most common psychological disorders, with prevalent onset in childhood and adolescence. while cognitive behavioral therapy (cbt) is considered the first-line treatment for pediatric anxiety, significant barriers remain in accessing cbt and other evidence-based treatments (ebts), and credible self-help resources based in ebt concepts. this study evaluates a family-guided cbt game application (anchors app), targeted to children ages 6-11 and their families, which focuses on delivering adaptive cbt-based coping skills to those who have sub-clinical to mild anxiety and related symptoms in a convenient and portable platform. anchors app will be evaluated in two forms (standard and "parent-enhanced") in comparison to use of a self-help book or waitlist control. the rapid advancements in technology allows richer interactive capacity, content scalability, customizability, and subscription to a broader range of content, which this app capitalizes on in order to increase access to cbt skill concepts directly to pediatric stakeholder populations. if found to be effective, anchors app has the opportunity to promote engagement of ebt concepts in every-day use through smartphone technology, and will change the landscape of mental health prevention and early intervention for children and families.


Eligibility criteria:
inclusion criteria: * availability of mobile technology (e.g., smart phone, tablet) * internet access * english language spoken in the home exclusion criteria: * child in current or recent (last 2 months) psychotherapy * child currently taking psychotropic medication * parent or child endorsing symptom greater than 2 standard deviations above the mean on clinical measures * parents express feeling unable to assist child with current degree of symptoms

Keywords: cbt self-help family
lymphedema study for arm or leg lymphedema

Conditions: Lymphedema

Summary: this study compares the effectiveness of a study drug versus placebo in the treatment of lymphedema.

part 1 is feasibility, exploratory, open-label study of ketoprofen, to document effects. part 2, is open-label trial of ketoprofen to document histological response. part 3 is double-blind randomized trial of receive placebo or ketoprofen to evaluate safety and efficacy. we will try to determine how the study drug affects the body tissue by obtaining tissue biopsies (small pieces of skin from the arm or leg) before treatment and after treatment.

Eligibility criteria:
inclusion criteria: * a history of lymphedema of one or more limbs (unilateral or bilateral), with a duration of \> 6 months. exclusion criteria: * patients with active cancer, infection or bleeding tendency will be excluded. * we will also exclude patients with medical contraindications to nsaids, including history of allergies, know gastrointestinal intolerance, or other serious systemic illness (e.g., renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would impair the patients' ability to participate. * minors (\ 90 years of age

Keywords: lymphedema edema swelling
single versus dual implant fixation of distal femur fractures

Conditions: Articular Fractures

Summary: the goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. the main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.

fractures of the distal femur are severe and common injuries sustained by wounded warriors in combat. despite advances in implant technology, these injuries continue to have an unacceptably high rate of nonunion (failure to heal) of approximately 20%. this adverse outcome requires additional surgery to achieve fracture healing, which prolongs recovery and further delays return to duty often beyond one year after injury. the goal of this study is to investigate a potential treatment for distal femur fractures that has the potential to improve the likelihood of fracture healing and accelerate return of patient function during the healing process.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * surgically treated displaced distal femur extra articular or complete articular fractures exclusion criteria: * patients with injury features that preclude treatment with 2 implants * patients unlikely to follow-up due to homelessness, or planning follow up at another institution * body mass index (bmi) \> 40 * injury due to ground level fall * patient that speaks neither english or spanish * patients with multisystem injuries that could preclude return to work * \< 18 years of age * prisoner

Keywords: distal femur fracture distal femur complete articular fracture distal femur extraarticular fracture
short-course radiotherapy combined with sintilimab for neoadjuvant treatment of esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this study is aimed to evaluate the efficacy and safety of short-course radiotherapy combined with sintilimab in neoadjuvant treatment of stage iii, locally advanced esophageal squamous cell carcinoma.

this study was designed as a single arm, phase ii trial. subjects will receive short-course radiotherapy combined with sintilimab as neoadjuvant therapy of stage iii, locally advanced esophageal squamous cell carcinoma. the primary endpoint is pathologic complete response(pcr).

Eligibility criteria:
inclusion criteria: * 18 years old and ≤75 years old * esophageal squamous cell carcinoma diagnosed biopsy histopathology * patients with resectable esophageal squamous cell carcinoma confirmed by pathology (including histology or cytology) , with pathological stage t3-4 or n+ * at least one measurable lesion * eastern cooperative oncology group (ecog) performance status of 0 to 1 * with adequate organs function exclusion criteria: * patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer * patients who have a higher risk of bleeding or perforation due to the tumor\&#39;s obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula * patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional chinese medicine therapy
special investigation of azithromycin iv for legionnaires' disease (regulatory post marketing commitment plan)

Conditions: Legionnaires' Disease; Legionella Pneumophila Infections

Summary: to collect retrospectively the efficacy and safety information of azithromycin iv on patients with legionnaires' disease related to their appropriate use in daily practice.


Eligibility criteria:
inclusion criteria: * all patients who are prescribed azithromycin (zithromac) iv for legionnaires' disease. exclusion criteria: * patients who have been prescribed zithromac or zithromac sr.

Keywords: legionnaires' disease legionella pneumophila zithromax zithromac japanese regulatory post marketing commitment plan
hrd and resistance to pappi in eoc patients

Conditions: Epithelial Ovarian Cancer; Homologous Recombination Deficiency; Homologous Recombination Repair Gene Mutation; Poly(ADP-ribose) Polymerase Inhibitor; Drug Resistance; Progression-free Survival; Overall Survival

Summary: the association between homologous recombination (hr) gene mutations and homologous recombination deficiency (hrd) status in chinese epithelial ovarian cancer (eoc) patients has been investigated in previous studies (nct04190667 and nct04651920). this study is to investigate the correlation between hrd and the resistance to poly(adp-ribose) polymerase inhibitors (parpi) in a chinese cohort confirmed of epithelial ovarian cancer. the mutated genes, hrd score model and their relationship with the prognosis is the primary endpoint in this study. all enrolled patients will accept parpi as maintenance therapy after the complete or partial remission of targeted lesions. a multiple panel testing of germline and somatic genes, including brca1/2, and hrd score are provided for all participants.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * pathological confirmation of epithelial ovarian cancer * with available tumor tissues * given consents to participate the study * with detailed follow-up outcomes exclusion criteria: * not meeting all of the inclusion criteria * declining to accept parpi as maintenance therapy after the major treatment for cancer
side effects screening and early intervention to impact in quality of life of gynaecological cancer patients

Conditions: Quality of Life; Gynaecological Cancer; Lymphedema, Lower Limb; Sexual Dysfunction

Summary: the goal of this randomized study is to assess the impact on self-perceived quality of life (qol) of systematic screening and early treatment of aftereffects in patients with gynaecological cancers. the main question it aims to answer is if systematic screening with validated questionaries (see in detailed description), diagnosis and early treatment of lower-limb lymphoedema, anxiety-depression, sexual dysfunction and sarcopenia-malnutrition all have a positive impact on the self-perceived qol by gynaecological cancer patients. participants will access the screening questionnaires and qol questionaries on a free online app on their mobile devices. in the experimental group, in case of positive screening, patients will be referred to specialised care to early treatment of the aftereffects. researchers will compare this group with standard usual care (opportunistic treatment) to see if systematic screening and early treatment lead to a better qol.

validated screening scales used: gynecologic cancer lymphedema questionnaire (gclq) hospital anxiety and depression scale (hads) sexual function abbreviated index (ifsfa-6) short nutritional assessment questionnaire (snaq) sarcopenia formulary (sarc-f) along with self-perceived quality of life questionnaires from eortc: qlq-c30 en-24 or ov-28 or cx-24

Eligibility criteria:
inclusion criteria: * women aged ≥18 diagnosed with ovarian, tubal and primary peritoneal, cervical and endometrial cancer who are candidates for surgery during the study period. exclusion criteria: * patients unable to complete by themselves the screening questionnaires included.

Keywords: quality of life gynaecological cancer
long term follow up patients with premature ovarian failure ex vivo gene therapy

Conditions: Primary Ovarian Insufficiency; Premature Ovarian Failure

Summary: this is a multi-centers of long term safety and efficacy follow up study for patients with premature ovarian failure (the women aged younger than 40 years, who present with amenorrhoea, hypergonadotropic hypogonadism, and infertility) who have been treated with ex vivo gene therapy drug product in institute of bio-stem cell rehabilitation uab - sponsored clinical studies. after completing the parent clinical study (approximately 6 month), eligible subject will be followed for additional 2 years for total of 2 years and 6 month post drug product infusion. no investigation drug product will be administered in the study


Eligibility criteria:
inclusion criteria: provision of written informed consent for this study by subjects or as applicable parent legal guardian. treated with drug product for therapy of premature ovarian insufficiency in a institute bio-stem cell rehabilitation uab clinical study. diagnosed of premature ovarian insufficiency eshre: * women age of 18 to 40 years * have experienced 4 months of oligo/amenorrhea * two serum follicle-stimulating hormone (fsh was \>40 miu/ml levels in the menopausal range, obtained at least a month apart * lower fsh levels ( 25 miu/ml) * anti-müllerian hormone (amh) serum levels ( 3.0 ng/ml) exclusion criteria: there are no exclusion criteria for this study

Keywords: premature ovarian failure stem cell therapy mesenchymal stem cell
study of the pharmacokinetics of golimumab in moderate to severe ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to gain insights in the pharmacokinetics of golimumab in moderate to severe ulcerative colitis after subcutaneous administration, during induction and maintenance treatment the investigators will collect blood and stool samples at different time points.

the pharmacokinetic characteristics of golimumab will be assessed by using blood and stool samples; collected during induction and maintenance treatment patients will undergo 13-16 blood sample collections, 13-16 stool sample collections and 3 endoscopies during 16 hospital visits in 1 year. they are also asked to fill in a short questionnaire (9x). at endoscopy visits a questionnaire regarding quality of life will be taken.the population pharmacokinetics of golimumab will be assessed using nonlinear mixed-effects modelling (non-mem).

Eligibility criteria:
inclusion criteria: * age from 18 years, either male or female * moderate to severe uc (according to mayo score (2 or 3) baseline endoscopy), both anti-tnf naïve and anti-tnf exposed patients will be included * baseline endoscopy * obtained written informed consent exclusion criteria: * contra-indication to golimumab: tbc, severe infections or congestive heart failure. * imminent need for surgery

Keywords: pharmacokinetics, golimumab, ibd
mixed incontinence: medical or surgical approach?

Conditions: Urinary Incontinence

Summary: the purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (mui) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. follow-up will be a minimum of 12 months.

the purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (mui) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. follow-up will be a minimum of 12 months.

Eligibility criteria:
inclusion criteria: 1. female 2. mixed ui as evidenced by stress and urge symptoms reported on mesa (either percent of urge-type symptoms ≥ the percent of stress-type symptoms or urge symptom score ≥7 if stress predominant) followed by report of "moderately" or "greatly"/"quite a bit" bothered to questions 2 and 3 of the 6-item urinary distress index (udi-6) or questions 16 and 17 of the 20-item pelvic fl;oor distress index (pfdi-20), respectively (see appendix c) 3. moderate or severe ui as evidenced by the corresponding response on the patient global impression of severity (pgi-s) 4. incontinence symptoms present for at least (3) months\* 5. bladder capacity \> 200cc (by any method) 6. urodynamic stress incontinence 7. eligible for both treatment interventions 8. available to start intervention within 6 weeks 9. negative urine dipstick (negative result = trace or less for leukocytes \& nitrites) 10. available for 12 months of follow-up and able to complete study assessments as per clinician judgment 11. signed consent form exclusion criteria: 1. age \<21 years\* 2. currently undergoing or recommended to undergo treatment of pelvic organ prolapse 3. other indicated/planned concomitant surgery 4. pregnant or has not completed child bearing\* 5. \<12 months post-partum\*† 6. active malignancy of cervix, uterus, fallopian tube(s) or ovary \> stage i, or bladder of any stage 7. current catheter use 8. unevaluated hematuria 9. participation in another trial that may influence the results of this study * patient can be rescreened after respective time interval has been met. †"partum" is defined as a delivery or other termination that occurs after 20 weeks gestation.

Keywords: stress urinary incontinence, mixed, urge